About FDA

What should parents be aware of before administering medication to a child?

Most medications prescribed for children have not been tested in children. By necessity, doctors give medications to children “off label” which means the drug has not been tested and FDA-approved for safety and effectiveness for use in children. Children are not small adults, and their growth and maturation from infancy to childhood affect how medications are handled by their body. The doctors often have to guess how much medication to give them, usually based on child’s weight and the dose is not adjusted to their unique biology. Since 1997, Congress passed laws that enable FDA to obtain better information by encouraging studies in children. Today 60% of medications have new dosage information for children in the product labeling. FDA is working to protect children by better understanding dosing in kids to make safer and more effective treatments.

Page Last Updated: 07/07/2016
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